Devices and methods for protecting against neuromas
The subject invention provides devices and methods for alleviating discomfort associated with neuroma formation. The devices and methods of the invention effectively use the body's natural response of reconstructing implanted biomaterials to minimize the size of, isolate, and protect a neuroma. In preferred embodiments, the subject device is a cylindrical cap, wherein the internal chamber of the cylindrical cap physically partitions the nerve to enable an arrangement of nerve fibers (as opposed to haphazardly arranged nerve fibers often produced in neuromas). Tabs arranged on the outside of the cap can be used to manipulate the cap into place on a nerve. The open end can also be configured with flaps that can be used to widen the open end for easier insertion of the nerve into the cap. In addition, the cap's material remodels into a tissue cushion after implantation, which protects the neuroma from being stimulated and inducing pain.
1. A device for alleviating discomfort associated with neuroma formation, the device comprising:
a body having an open proximal end and a closed distal end;
an internal chamber defined by the body;
at least one divider within the internal chamber that subdivides at least a portion of the internal chamber, wherein the at least one divider extends from a distal end of the internal chamber to a region between the proximal end of the body and the distal end of the internal chamber so that the at least one divider subdivides 25% to 75% of a length of the internal chamber into separate channels;
wherein the internal chamber includes an undivided retaining cavity located between the proximal end of the body and a proximal end of the at least one divider; and
at least one tab extending out from an external surface of the body.
2. The device of claim 1 , wherein the body of the device is 1 mm to 500 mm in length.
3. The device of claim 1 , wherein the body of the device is 1 mm to 100 mm in diameter.
4. The device of claim 1 , wherein the at least one divider extends along 40% to 60% of the length of the internal chamber.
5. The device of claim 1 , wherein the at least one divider extends along 50% of the length of the internal chamber.
6. The device of claim 1 , wherein the at least one divider is a panel divider.
7. The device of claim 1 , wherein the at least one divider includes a plurality of panel dividers so that the internal chamber is divided into more than two separate channels.
8. The device of claim 7 , wherein the plurality of panel dividers includes at least two panel dividers arranged perpendicular to one another.
9. The device of claim 7 , wherein the plurality of panel dividers includes at least two panel dividers arranged parallel to one another.
10. The device of claim 1 , wherein the at least one tab includes a tab extending out from the distal end of the body.
11. The device of claim 10 , wherein the tab extending out from the distal end of the body lies in a plane that includes the at least one divider.
12. The device of claim 1 , wherein the at least one tab includes a tab extending out from a side of the body.
13. The device of claim 1 , wherein the at least one tab incudes a tab extending parallel to a longitudinal axis of the device.
14. The device of claim 1 , wherein the at least one tab incudes a tab extending perpendicular to a longitudinal axis of the device.
15. The device of claim 1 , wherein the at least one tab incudes a tab extending at an oblique angle relative to a longitudinal axis of the device.
16. The device of claim 1 , wherein the body has a diameter at a distal end region that is less than a diameter at a proximal end region.
17. The device of claim 1 , wherein the body has a diameter at a distal end region that is equal to a diameter at a proximal end region.
18. The device of claim 1 , wherein the device comprises a biomaterial selected from the group consisting of: high-density polyethylene (HDPE), polyethylene glycol (PEG) hydrogel, purified protein from human or animal sources, and decellularized tissue constructs.
19. The device of claim 18 , wherein the biomaterial is selected from the group consisting of: collagen, fibrin, demineralized bone, amnion, small intestine submucosa (SIS), dermis, or fascia.
20. The device of claim 19 , wherein the device comprises porous HDPE or PEG surrounded by a layer of non-porous HDPE or PEG.
21. The device of claim 1 , wherein the body has a cylindrical shape.
22. The device of claim 1 , further comprising a slit extending from the proximal end towards the distal end.
23. The device of claim 22 , wherein the body includes one or more flaps that at least partially surround the retaining cavity.
24. The device of claim 1 , further comprising at least one flap.
25. The device of claim 24 , wherein the at least one flap includes a single flap that extends along at least one of: (i) 25% to 75% of a periphery of the open proximal end; (ii) 35% to 65% of a periphery of the open proximal end; or 45% to 55% of a periphery of the open proximal end.
26. The device of claim 24 , wherein the at least one flap includes two flaps that together extend along 25% to 75% of a periphery of the open proximal end.
27. The device of claim 24 , wherein the at least one flap includes two flaps that are configured to open in opposite directions from one another.
28. The device of claim 24 , wherein at least a portion of the retaining cavity is located between a distal edge of the at least one flap and the proximal end of the at least one divider.
29. The device of claim 24 , wherein none of the retaining cavity is located between a distal edge of the at least one flap and the proximal end of the at least one divider.
30. The device of claim 24 , wherein a distal edge of the at least one flap is aligned with the proximal end of the at least one divider.